COFEPRIS Inspections
COFEPRIS has authority to inspect any facility involved in the manufacture, import, storage, or distribution of medical devices in Mexico. Inspections are a key enforcement mechanism and may occur at any time — including without prior notice.
Types of inspection
| Type | Description |
|---|---|
| Routine inspection | Scheduled inspection of registered facilities as part of regular oversight |
| Cause inspection | Triggered by a complaint, adverse event, or suspected non-compliance |
| Follow-up inspection | Verifies that corrective actions from a prior inspection have been implemented |
| Pre-registration inspection | May be conducted as part of reviewing a new registration application |
| Unannounced inspection | COFEPRIS may inspect without prior notice at any time |
What inspectors assess
Inspectors typically evaluate:
- GMP compliance with NOM-241-SSA1-2025.
- Quality system documentation — procedures, records, CAPA logs.
- Physical conditions — storage, manufacturing, cleanliness, segregation.
- Traceability — ability to trace devices from receipt through to distribution.
- Technovigilance system — procedures, personnel, reporting records.
- Labelling compliance — NOM-137.
- Regulatory documentation — registration certificates, Aviso de funcionamiento, Responsable Sanitario credentials.
After the inspection — the inspection report
COFEPRIS issues an inspection report (acta de inspección) documenting findings. Non-conformities may be classified as:
- Minor — low risk; corrective action within a defined timeframe.
- Major — significant risk; requires prompt corrective action.
- Critical — imminent risk; may trigger immediate enforcement action.
Responding to inspection findings
- Acknowledge findings within the timeframe specified by COFEPRIS.
- Provide a corrective action plan (CAPA) addressing root cause, not just the symptom.
- Implement corrections and retain evidence of implementation.
- Submit the CAPA response to COFEPRIS within the specified deadline.
- COFEPRIS may conduct a follow-up inspection to verify effectiveness.
Enforcement actions
If COFEPRIS determines serious non-compliance, it may:
- Issue formal warnings (apercibimientos).
- Impose monetary fines per the sanction catalogue.
- Suspend the facility's Aviso de funcionamiento.
- Cancel the sanitary registration.
- Order product withdrawal from the market.
Practical preparation
- Maintain all GMP documentation in accessible, organised form.
- Ensure the Responsable Sanitario is present or reachable during business hours.
- Conduct regular internal audits against NOM-241 requirements.
- Brief all key personnel on inspection protocols.
- Have a documented procedure for receiving inspectors and managing the inspection process.